BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER

    MDR report key: 437569 · Received January 13, 2003

    Report

    Report Number
    2029214-2003-00001
    Event Type
    Other
    Date Received
    January 13, 2003
    Date of Event
    December 9, 2002
    Report Date
    January 9, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE RUPTURED DURING CONTRAST MEDIA INJECTION (ULTRAVIST 300, DILUTED 50:50). IT WAS THE 2ND INJECTION, AND NO RESISTANCE WAS FELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER NEURO MICRO CATHETER DYG MICRO THERAPEUTICS, INC. 105-5056 921254J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN